[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408407":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":57,"collaborators":60,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":9,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":24,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":101,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"UConn Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid Package Prototype (OPP)","EXPERIMENTAL","Oxycodone 5mg tablets dispensed in the Opioid Package Prototype (OPP) with frequency and quantities varying, depending on the type of surgical procedure performed, surgeon, and individual patient",[13],"Other: Opioid Package Prototype (OPP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care (standard amber vial)","ACTIVE_COMPARATOR","Oxycodone 5mg tablets dispensed in the standard amber vial (usual care) with frequency and quantities varying, depending on the type of surgical procedure performed, surgeon, and individual patient",[19],"Other: Usual Care (standard amber vial)",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"The Opioid Package Prototype (OPP) is a child-resistant\u002Fsenior-friendly, calendar-blister packaging of limited pill counts with flat readable billboard space for medication labeling.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.",[15],[29],{"name":30,"affiliation":31,"role":32},"Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA","University of Connecticut","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","860-486-6026","nathaniel.rickles@uconn.edu",[39],{"facility":5,"status":24,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Farmington","Connecticut","06030","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-72.83204,41.71982,{"lat":49,"lon":48},[52,53,54],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":30,"role":32,"phone":24,"phoneExt":24,"email":24},{"name":55,"role":56,"phone":24,"phoneExt":24,"email":24},"Katherine J Coyner, MD, FAOA","SUB_INVESTIGATOR",{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Nathaniel Rickles","Professor of Pharmacy Practice",[61,62],{"name":31,"class":6},{"name":63,"class":64},"Food and Drug Administration (FDA)","FED","100408407","opioid-package-prototype-opp-100408407",false,"NCT04598074","The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes","Inclusion Criteria:\n\n1. The patient is 18 years and older;\n2. The patient is one of the participating surgeons;\n3. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;\n4. The patient is willing to receive oxycodone medication;\n5. The patient is willing and able to receive medication at the UConn Health Specialty Pharmacy, located in the Exchange across the street from the main entrance of UConn Health;\n6. The patient is willing and able to use a MyChart account;\n7. The patient is able to read and understand English; and\n8. The patient is able to understand the study procedures and their involvement in the study.\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":74,"type":75},352,"ESTIMATED","INTERVENTIONAL",[78],"NA","The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.",[81,82],"Opioid Use","Opioid Prescribing, Dispensing, and Patient Use",[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"oxycodone","opioid","opioids","package","packaging","post-surgical pain","post-operative pain","orthopedic","orthopaedic","surgery","dispensing","prescribing","blister","tablets","pain","opioid package prototype","OPP","NOT_YET_RECRUITING","2025-08-29",{"date":104,"type":105},"2025-09-05","ACTUAL",{"date":107,"type":75},"2025-09-07",{"date":109,"type":75},"2026-09-30",{"name":5,"class":6},1]